An Open-Label, Phase II Trial to Assess Efficacy and Safety of Onvansertib in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Previously Untreated, Locally-Advanced or Unresectable Pancreatic Adenocarcinoma

This phase II trial studies how well onvansertib in combination with gemcitabine and nab-paclitaxel works in treating patients with pancreatic ductal carcinoma (PDAC) that has spread to nearby tissue or lymph nodes (locally advanced), that cannot be removed by surgery (unresectable), or that has spread from where it first started (primary site) to other places in the body (metastatic). Onvansertib is a small chemical molecule that binds and stops the function of of PLK1 in tumor cells. By attacking the PLK1 protein, onvansertib is thought to reduce tumor cells ability to replicate and grow; causing them to die. Chemotherapy drugs, such as gemcitabine and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with onvansertib may kill more tumor cells in patients with locally-advanced, unresectable, or metastatic pancreatic ductal carcinoma.

Start Date01 Aug 2024

Sponsor / Collaborator

OHSU Knight Cancer Institute

[+1]

NCT06106308 / RecruitingPhase 2

A Phase 2, Randomized, Open-label Study of Onvansertib in Combination with FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS or NRAS Mutation

The purpose of this study is to assess 2 different doses of onvansertib to select the lowest dose that is maximally effective, and to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of onvansertib in combination with FOLFIRI + bevacizumab or FOLFOX + bevacizumab in patients with KRAS or NRAS-mutated metastatic colorectal cancer (CRC) in the first-line setting.

Start Date27 Feb 2024

Sponsor / Collaborator

Cardiff Oncology, Inc.

[+1]

NCT05549661 / RecruitingPhase 1IIT

Phase 1 Study to Determine the Safety and Efficacy of Onvansertib, a Novel, Oral, PLK1 Inhibitor in Patients with Proliferative Chronic Myelomonocytic Leukemia (CMML) Relapsed/Refractory or Intolerant to Available Therapies

This phase I trial evaluates the safety, effectiveness, and best dose of onvansertib for the treatment of patients with chronic myelomonocytic leukemia that has come back (recurrent) or that does not respond to treatment (refractory). Onvansertib is a drug that binds to and inhibits an enzyme called PLK1, preventing cancer cell proliferation and causing cell death.

Start Date04 Apr 2023

Sponsor / Collaborator

Mayo Clinic

100 Clinical Results associated with Onvansertib

100 Translational Medicine associated with Onvansertib

100 Patents (Medical) associated with Onvansertib

Literatures (Medical) associated with Onvansertib

01 Oct 2024·MOLECULAR CANCER THERAPEUTICS

AKT Inhibition Sensitizes to Polo-Like Kinase 1 Inhibitor Onvansertib in Prostate Cancer

Article

Author: Isaacs, John T. ; Brennen, W.N. ; Dennehy, Christopher M. ; Balk, Steven P. ; Einstein, David J. ; Nouri, Mannan ; Ridinger, Maya ; Dalrymple, Susan L. ; Varkaris, Andreas

Abstract:

Polo-like kinase 1 (PLK1) inhibitors have had limited antitumor efficacy as single agents, and focus of current efforts is on combination therapies. We initially confirmed that the PLK1-specific inhibitor onvansertib (ONV) could enhance responses to a PARP inhibitor (olaparib) in prostate cancer xenografts. To identify more effective combinations, we screened a library of bioactive compounds for efficacy in combination with ONV in LNCaP prostate cancer cells, which identified a series of compounds including multiple AKT inhibitors. We confirmed in vitro synergy between ONV and the AKT inhibitor ipatasertib (IPA) and found that the combination increased apoptosis. Mechanistic studies showed that ONV increased expression of the antiapoptotic protein SURVIVIN and that this was mitigated by IPA. Studies in three PTEN-deficient prostate cancer xenograft models showed that cotreatment with IPA and ONV led to significant tumor growth inhibition compared with monotherapies. Together, these in vitro and in vivo studies demonstrate that the efficacy of PLK1 antagonists can be enhanced by PARP or AKT inhibition and support further development of these combination therapies.

15 May 2024·Clinical cancer research : an official journal of the American Association for Cancer Research

Onvansertib in Combination with FOLFIRI and Bevacizumab in Second-Line Treatment of KRAS-Mutant Metastatic Colorectal Cancer: A Phase Ib Clinical Study

Article

Author: Samuëlsz, Errin ; Lenz, Heinz-Josef ; Subramanian, Ramanand A. ; Ahn, Daniel H. ; Smeal, Tod ; Kabbinavar, Fairooz F. ; Croucher, Peter J.P. ; Ridinger, Maya ; Barzi, Afsaneh

Abstract:

Purpose::

Onvansertib is a highly specific inhibitor of polo-like kinase 1 (PLK1), with demonstrated safety in solid tumors. We evaluated, preclinically and clinically, the potential of onvansertib in combination with chemotherapy as a therapeutic option for KRAS-mutant colorectal cancer.

Patients and Methods::

Preclinical activity of onvansertib was assessed (i) in vitro in KRAS wild-type and -mutant isogenic colorectal cancer cells and (ii) in vivo, in combination with irinotecan, in a KRAS-mutant xenograft model. Clinically, a phase Ib trial was conducted to investigate onvansertib at doses 12, 15, and 18 mg/m2 (days 1–5 and 14–19 of a 28-day cycle) in combination with FOLFIRI/bevacizumab (days 1 and 15) in patients with KRAS-mutant metastatic colorectal cancer who had prior oxaliplatin exposure. Safety, efficacy, and changes in circulating tumor DNA (ctDNA) were assessed.

Results::

In preclinical models, onvansertib displayed superior activity in KRAS-mutant than wild-type isogenic colorectal cancer cells and demonstrated potent antitumor activity in combination with irinotecan in vivo. Eighteen patients enrolled in the phase Ib study. Onvansertib recommended phase II dose was established at 15 mg/m2. Grade 3 and 4 adverse events (AE) represented 15% of all treatment-related AEs, with neutropenia being the most common. Partial responses were observed in 44% of patients, with a median duration of response of 9.5 months. Early ctDNA dynamics were predictive of treatment efficacy.

Conclusions::

Onvansertib combined with FOLIFRI/bevacizumab exhibited manageable safety and promising efficacy in second-line treatment of patients with KRAS-mutant metastatic colorectal cancer. Further exploration of this combination therapy is ongoing.See related commentary by Stebbing and Bullock, p. 2005

15 May 2024·Clinical cancer research : an official journal of the American Association for Cancer Research

Polo-like Kinase 1 Inhibition inKRAS-Mutated Metastatic Colorectal Cancer

Article

Author: Bullock, Andrea J. ; Stebbing, Justin

Summary::

Inhibition of Polo-like kinase 1 (Plk1) is a promising new target and therapeutic strategy in metastatic colorectal cancer, especially those with KRAS mutations. New data support further development of onvansertib, and highlights the role of circulating tumor DNA in phase I clinical trials.See related article by Ahn et al., p. 2039

News (Medical) associated with Onvansertib

18 Dec 2024

·www.prnewswire.com

Cancer Care Disruptions Highlight Growing Demand for Innovative Oncology Treatments

USA News Group Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Dec. 18, 2024 /PRNewswire/ -- USA News Group News Commentary – The American Cancer Society recently released its Advances in Oncology – 2024 Research Highlights report that highlighted how their scientists continued to set the standard for research and innovation over the course of the year. However, along with the report's optimism, the American Cancer Society also recently released a study finding that early-onset colorectal cancer cases are surging globally, signaling an alarming trend. A new article published in Nature showed that the COVID-19 pandemic severely disrupted cancer care, causing delays in diagnosis, treatment, and screening services, which likely led to more advanced disease stages, poorer survival outcomes, and significant challenges in accurately interpreting long-term cancer survival data. In the world of oncology, there are still several challenges that need to be addressed and new treatments to be rolled out, but thankfully, there have been several recent developments coming out from innovators, including O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Cardiff Oncology, Inc. (NASDAQ: CRDF), OS Therapies, Inc. (NYSE-American: OSTX), Checkpoint Therapeutics, Inc. (NASDAQ: CKPT), and Eli Lilly and Company (Lilly) (NYSE: LLY). The article continued: Not long ago, the American Cancer Society sounded the alarm on a surging rise in cancer diagnoses and fatalities among younger. For the industry targeting the alarming issue, analysts at Exactitude Consultancy project the Cancer Immunotherapy Market to expand at a 12.84% CAGR, reaching $258.22 billion by the end of 2031, further solidifying oncology as a dynamic and evolving sector. Oncolytics Biotech® to Present Promising Pelareorep Data in Pancreatic and Anal Cancers at ASCO GI Symposium Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced the presentation of two data sets through two abstracts showcasing pelareorep's potential in difficult-to-treat gastrointestinal cancers, which were accepted and will be presented at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco January 23-25, 2025. "We are enthusiastic about pelareorep's applicability across multiple gastrointestinal cancer indications, including pancreatic and anal cancer," said Tom Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics. "Pelareorep engages patients' immune systems to help make commonly used chemotherapies and checkpoint inhibitors, such as atezolizumab, more effective in fighting cancer. This offers the promise of delaying disease progression and improving survival in patients with these devasting diseases. Given the versatility of pelareorep, we see multiple clinical and regulatory options for bringing this promising medicine to patients." Oncolytics will present two key data sets from the GOBLET study, with preliminary safety and tumor response results for the relapsed anal carcinoma cohort treated with pelareorep and atezolizumab presented in Poster Session C on January 25, 2025, from 7:00 to 7:55 a.m. PT. Additionally, results from the safety run-in phase for first-line metastatic pancreatic ductal adenocarcinoma patients treated with pelareorep, modified FOLFIRINOX, with and without atezolizumab will be presented in Poster Session B on January 24, 2025, from 11:30 a.m. to 1:00 p.m. PT. Both abstracts will be available on the ASCO Gastrointestinal Cancers Symposium website at 5:00 p.m. ET on January 21, 2025. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Cardiff Oncology, Inc. (NASDAQ: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, recently announced positive initial data from CRDF-004, a randomized, Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care (SoC) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). Efficacy and safety data are for all evaluable patients as of a November 26, 2024, data cut-off date, and all efficacy data are determined by a blinded, independent central review (BICR) of each patient's tumor scan. "We are highly encouraged by the robust efficacy signal and favorable safety profile observed with onvansertib plus standard-of-care from the first 30 evaluable patients in our randomized first-line RAS-mutated mCRC CRDF-004 trial," said Fairooz Kabbinavar, MD, FACP, Chief Medical Officer of Cardiff Oncology. "Our data shows an objective response rate of 64% in patients receiving the 30 mg dose of onvansertib in combination with standard of care, significantly higher than the 33% objective response rate observed in the control arms of standard of care alone. In addition, as can be seen in the spider plots, we are observing deeper tumor response in patients receiving the 30mg dose of onvansertib compared to those receiving the 20mg dose with similar safety profiles for both doses." OS Therapies, Inc. (NYSE-American: OSTX), a clinical-stage cancer immunotherapy and antibody-drug conjugate biotechnology company, recently reported its Q3 2024 financial results for the quarter and provided a business update. Within the quarter, OS Therapies completed dosing all patients in its potentially pivotal Phase 2b clinical trial of OST-HER2 for resected, recurrent osteosarcoma and is preparing to release topline data in December. The company also joined Johnson & Johnson's JLABS program, completed its IPO on the NYSE American, and is in active discussions with the FDA regarding Breakthrough Therapy Designation for OST-HER2. "The third quarter was pivotal for OS Therapies as we completed our initial public offering and finished dosing the final patient enrolled in our Phase 2b clinical trial of OST-HER2 in resected, recurrent osteosarcoma," said Paul Romness, MHP, Chairman and CEO of OS Therapies. "We are now looking forward to releasing topline data in December and then engaging with the FDA regarding getting this potentially life-saving cancer immunotherapy to patients that have no other potential treatment options as quickly as possible." Checkpoint Therapeutics, Inc. (NASDAQ: CKPT), a commercial-stage immunotherapy and targeted oncology company focused on novel treatments for patients with solid tumor cancers, recently announced that the FDA approved its UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or curative radiation. UNLOXCYT is the first and only programmed death ligand-1 (PD-L1) blocking antibody to receive FDA marketing approval for this indication. "[This] FDA approval of UNLOXCYT – the first marketing approval for our company – is a significant milestone both for Checkpoint and for patients with advanced cSCC," said James Oliviero, President and CEO of Checkpoint. "This approval marks Checkpoint's transformation to a commercial-stage company, with the opportunity to compete in a U.S. market estimated to exceed $1 billion annually, where we believe UNLOXCYT offers a differentiated treatment option versus available therapies by binding to PD-L1, rather than programmed death receptor-1 (PD-1), to release the inhibitory effects of PD-L1 on the anti-tumor immune response. Additionally, UNLOXCYT has demonstrated the ability to induce antibody-dependent cell-mediated cytotoxicity (ADCC), another potential differentiating feature of the drug compared to existing marketed therapies for patients with cSCC." Eli Lilly and Company (Lilly) (NYSE: LLY), a medicine company turning science into healing to make life better for people around the world, recently announced results from its Phase 3 BRUIN CLL-321 trial, which tested pirtobrutinib, a next-generation treatment for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had previously been treated with a similar type of drug. The study showed that pirtobrutinib significantly reduced the risk of disease progression or death by 46% compared to standard treatments (idelalisib plus rituximab or bendamustine plus rituximab). These promising results were presented at the 66th American Society of Hematology (ASH) Annual Meeting. "BRUIN CLL-321 is the only randomized CLL or SLL study ever conducted exclusively in the BTK-inhibitor pre-treated population, where there is significant need for new treatment options, and these data illustrate pirtobrutinib's ability to meaningfully delay disease progression and time to next treatment in this setting," said David Hyman, M.D., Chief Medical Officer of Lilly. "This is the first in our suite of randomized Phase 3 trials for pirtobrutinib to readout and we look forward to continuing to build the body of evidence supporting the role of pirtobrutinib in advancing care for people with B-cell malignancies." Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCE USA News Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Drug ApprovalImmunotherapyClinical ResultASCO

13 Dec 2024

·www.globenewswire.com

Cardiff Oncology Announces Positive Initial Data from First-line RAS-mutated mCRC Clinical Trial

- Initial results from randomized Phase 2 CRDF-004 trial evaluating onvansertib + standard of care in RAS-mut mCRC demonstrated 64% ORR in the 30mg onvansertib dose arm versus 33% ORR in the control arm - - In the experimental arms, 30mg dose of onvansertib demonstrated a higher ORR compared to 20mg dose of onvansertib (64% vs. 50%) with deeper tumor regression in the 30mg arm - - Onvansertib was well tolerated at both doses - - Additional clinical data from CRDF-004 trial expected in 1H 2025 - - Company will hold a conference call today at 8:00 a.m. ET / 5:00 a.m. PT - Dec. 10, 2024 -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced positive initial data from CRDF-004, a randomized, Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care (SoC) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). Efficacy and safety data are for all evaluable patients as of a November 26, 2024 data cut-off date, and all efficacy data are determined by a blinded, independent central review (BICR) of each patient’s tumor scan. “We are highly encouraged by the robust efficacy signal and favorable safety profile observed with onvansertib plus standard-of-care from the first 30 evaluable patients in our randomized first-line RAS-mutated mCRC CRDF-004 trial,” said Fairooz Kabbinavar, MD, FACP, Chief Medical Officer of Cardiff Oncology. “Our data shows an objective response rate of 64% in patients receiving the 30 mg dose of onvansertib in combination with standard of care, significantly higher than the 33% objective response rate observed in the control arms of standard of care alone. In addition, as can be seen in the spider plots, we are observing deeper tumor response in patients receiving the 30mg dose of onvansertib compared to those receiving the 20mg dose with similar safety profiles for both doses.” The CRDF-004 phase 2 trial is currently enrolling patients with mCRC who have a documented KRAS or NRAS mutation. Onvansertib is added to SoC consisting of FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab. Patients are being randomized in a 1:1:1 ratio to either 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone. The primary endpoint is objective response rate (ORR), and the secondary endpoints include progression-free survival (PFS), duration of response (DOR) and safety. Objective Response Rates observed in the CRDF-004 clinical trial, as of the data cut-off date of November 26, 2024, are shown below. Spider Plots, displaying the change in tumor size from baseline for each patient over time, demonstrate deeper responses observed in patients receiving the 30mg dose of onvansertib in combination with the SoC compared to both the control arms and 20mg dose of onvansertib arms. Note: Radiographic response determined per RECIST 1.1 by blinded independent central review. Spider plot reflects interim data as of November 26, 2024 from an ongoing trial and unlocked database. Additional clinical data from CRDF-004 trial expected in 1H 2025 Cardiff Oncology will host a conference call and live webcast at 8:00 a.m. ET / 5:00 a.m. PT on December 10, 2024. Individuals interested in listening to the live conference call may do so by using the webcast link in the "Events" section of the company's website. A webcast replay will be available in the investor relations section on the company's website following the completion of the call. Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard of care (SoC) therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (mCRC), as well as in ongoing and planned investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC) and triple negative breast cancer (TNBC). These programs and the Company's broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to SoC alone. For more information, please visit https://www.cardiffoncology.com. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultASCO

10 Dec 2024

·www.globenewswire.com

Cardiff Oncology Prices Oversubscribed $40 Million Underwritten Registered Direct Offering

SAN DIEGO, Dec. 10, 2024 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF) (“Cardiff Oncology” or the “Company”), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced the pricing of an underwritten offering of 15,384,619 shares of its common stock at an offering price of $2.60 per share, before deducting underwriting discounts and commissions. All of the shares of common stock are being offered by the Company. The financing included participation from new mutual fund and healthcare dedicated investors, along with support from existing investors. The gross proceeds to the Company, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $40 million. The offering is expected to close on or about December 11, 2024, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from this offering to fund clinical costs for onvansertib in first-line RAS-mutated metastatic colorectal cancer (mCRC) and for working capital and other general corporate purposes. TD Cowen is acting as lead book-runner for the offering. William Blair is also acting as book-runner, H.C. Wainwright & Co. is acting as lead manager, and Craig-Hallum is acting as co-manager for the offering. The offering is being made pursuant to a shelf registration statement on Form S-3 previously filed with the U.S. Securities and Exchange Commission (“SEC”) and declared effective by the SEC on April 25, 2022. A prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC. Copies of the prospectus supplement and the accompanying prospectus, may be obtained, when available, by contacting TD Securities (USA) LLC, 1 Vanderbilt Ave., New York, NY 10017, by telephone at (855) 495-9846, or by email at TD.ECM_Prospectus@tdsecurities.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction. About Cardiff Oncology, Inc. Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard-of-care (SoC) therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (mCRC) and metastatic pancreatic ductal adenocarcinoma (mPDAC), as well as in investigator-initiated trials in small cell lung cancer (SCLC) and triple negative breast cancer (TNBC). These programs and the Company's broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the SoC alone. Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern the Company’s expectations, strategy, plans or intentions. These forward-looking statements are based on the Company’s current expectations and actual results could differ materially. Forward-looking statements include statements regarding the closing of the offering of common stock; and the Company’s intended use of proceeds. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the satisfaction of customary closing conditions related to the offering, our need for additional financing; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; the Company’s clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of the Company’s product candidate; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain U.S. Food and Drug Administration (“FDA”) clearances or approvals and noncompliance with FDA regulations. There are no guarantees that the Company’s product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that any precision medicine therapeutics will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the SEC. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and the Company does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances. Cardiff Oncology Contact:James LevineChief Financial Officer858-952-7670jlevine@cardiffoncology.com Investor Contact:Kiki Patel, PharmD Gilmartin Group332-895-3225Kiki@gilmartinir.com Media Contact:Grace SpencerTaft Communications609-583-1151grace@taftcommunications.com

Clinical Study

100 Deals associated with Onvansertib

External Link

KEGG	Wiki	ATC	Drug Bank
D11458	-	-	DB15110

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Pancreatic Adenocarcinoma	Phase 2	-	Cardiff Oncology, Inc.	01 Jan 2025
Metastatic Colorectal Carcinoma	Phase 2	US	Cardiff Oncology, Inc.	17 Mar 2023
HER2-negative breast cancer	Phase 2	US	Cardiff Oncology, Inc.	30 Sep 2022
Hormone Receptor Positive Breast Adenocarcinoma	Phase 2	US	Cardiff Oncology, Inc.	30 Sep 2022
hormone receptor/growth factor receptor-negative breast cancer	Phase 2	US	Cardiff Oncology, Inc.	30 Sep 2022
Inflammatory Breast Neoplasms	Phase 2	US	Cardiff Oncology, Inc.	30 Sep 2022
Invasive Mammary Carcinoma	Phase 2	US	Cardiff Oncology, Inc.	30 Sep 2022
Locally advanced breast cancer	Phase 2	US	Cardiff Oncology, Inc.	30 Sep 2022
Metastatic breast cancer	Phase 2	US	Cardiff Oncology, Inc.	30 Sep 2022
Unresectable Breast Carcinoma	Phase 2	US	Cardiff Oncology, Inc.	30 Sep 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03414034 (CTgov)	Phase 2	Metastatic castration-resistant prostate cancer	72	Prednisone+Abiraterone+Onvansertib (Arm A: Onvansertib + Abiraterone and Prednisone)	nvuajiwphb(bxqxqtvjlx) = gaaayedqyp jubrxhegny (uoybasfjzn, rydzgbrhzr - aqllanxpix) View more	-	07 Nov 2024
				Prednisone+Abiraterone+Onvansertib (Arm B: Onvansertib + Abiraterone and Prednisone)	nvuajiwphb(bxqxqtvjlx) = oeqqqaosip jubrxhegny (uoybasfjzn, lufptujlrl - moobwgtlhu) View more
NCT03829410 (CRDF-004, GlobeNewswire) Manual	Phase 2	KRAS mutant Colorectal Cancer Second line KRAS Mutation	-	Onvansertib with FOLFIRI and bevacizumab (bev-naïve patients)	ztrylymkla(svmhbggmqk) = ntzmjcryhh qwtthihgbj (njryaeimkg ) View more	Positive	30 Oct 2024
				onvansertib with FOLFIRI and bevacizumab (bev-exposed patients)	ztrylymkla(svmhbggmqk) = ystszuurem qwtthihgbj (njryaeimkg ) View more
NCT03829410 (AACR2024) Manual	Phase 1/2	KRAS mutant Colorectal Cancer Second line KRAS-mutant	66	Onvansertibbevacizumab	loinqehnxt(duieiinzgz) = ecqrnknbqr hjvryaaump (pgtugtkulq ) View more	Positive	22 Mar 2024
NCT05593328 (ONSEMBLE, GlobeNewswire) Manual	Phase 2	Metastatic Colorectal Carcinoma Second line KRAS Mutation \| NRAS Mutation	23	Onvansertib+SoC	fpxbhqbgii(jqmgxavrid) = habcsazkdq fmuhpwaxxm (hmerovzndn ) View more	Positive	29 Feb 2024
				Onvansertib+SoC (Bev Naïve patients)	fpxbhqbgii(jqmgxavrid) = ruvagnacvq fmuhpwaxxm (hmerovzndn )
Literature Manual	Phase 1	KRAS mutant Colorectal Cancer Second line KRAS Mutation	18	Onvansertib+FOLFIRI+Bevacizumab	koveojmryp(jsfikaijkw) = ubkfzhdfac ejxxafbscc (dkaaifnqxi ) View more	Positive	17 Jan 2024
NCT04752696 (CRDF-001, Corporate Publications) Manual	Phase 2	Small Cell Lung Cancer \| Pancreatic Cancer Second line	-	Onvansertib+nanoliposomal irinotecan+leucovorin+fluorouracil	ouirdlztan(ylxleocmap) = xmkgryljxp hwgaqxmngb (lreapsfwra ) View more	Positive	26 Sep 2023
				Standard-of-care	ouirdlztan(ylxleocmap) = gqbvgwssoj hwgaqxmngb (lreapsfwra ) View more
NCT03829410 (ESMO2022)	Phase 2	Metastatic Colorectal Carcinoma	48	Onvansertib + FOLFIRI/bev	rfjiazpeqt(dccsdietni) = featqatovh sewavkbzvj (cahlufxcxn ) View more	-	10 Sep 2022
NCT03829410 (ASCO_GI2022) Manual	Phase 1/2	KRAS mutant Colorectal Cancer Second line KRAS Mutation	50	FOLFIRI-bev+onvansertib (Ph1b)	noyorlbttr(vovgdrpypx) = ehfjrzqjif bmgwysfjoi (cbyxufywae ) View more	Positive	19 Jan 2022
				FOLFIRI-bev+onvansertib (Ph2)	-
NCT03414034 (Corporate Publications) Manual	Phase 2	Metastatic castration-resistant prostate cancer	56	Abiraterone+Onvansertib (Arm A)	ehxxucqdhg(ubbacabiow) = xuddrlvtdl ghidorzvwo (spwqcdsjan ) View more	Positive	20 Oct 2020
				Abiraterone+Onvansertib (Arm B)	ehxxucqdhg(ubbacabiow) = irwddhvbsb ghidorzvwo (spwqcdsjan ) View more
NCT03829410 (ESMO2020)	Phase 2	KRAS mutant Colorectal Cancer Second line	9	Onvansertib + FOLFIRI-bev	nufhgqsgef(tfqeztuspv) = Most common all-causality adverse events (AEs) were fatigue, diarrhea, nausea and neutropenia csrkodvbnc (rvyslczpun ) View more	Positive	17 Sep 2020

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